Moist heat drug delivery apparatus and method

ABSTRACT

A novel moist steam heating cabinet unit is used as a medical device for humidification, hydration, and dispensing of medicinal hot packs. The technology provides multifunctional options from both medicine and non-medicinal hot pack treatment, as well as for other applications and uses, for example—including creation, manufacturing, and curing of pharmaceutical compounds that require a controlled steam process and method. A moist heating device is a unit designed and constructed to deliver a timed, heated fluidic steam coming from a moisture-heating source. This moist heating by employing steam heat activates the therapeutic potential of a portable topical compress or hot pack with a applicator of various shapes and sizes, for transdermal use and neat applications of a “wet medicinal dressing.” The moisture provides the activating liquid and fluidic environment for the flowing through, titrating, and permeating delivery of hydrous and anhydrous drugs or medicaments held within a medicinal pack.

RELATED APPLICATIONS

This application claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 13/154,431 filed Jun. 6, 2011 and entitled “Moist Heat Drug Delivery Apparatus And Method,” which claims priority to U.S. Provisional Patent Application No. 61/351,289 filed Jun. 4, 2010 and entitled “Medicinal Dispensing Apparatus And Method.” The complete disclosure of each of the above-identified priority applications is hereby fully incorporated herein by reference.

BACKGROUND

Historically over thousands of years, medicinal packs have been applied as a “stupe” (a hot, wet, often medicated cloth used as a compress) for topical, transdermal applications. Conventional medicinal packs or stupes can be applied to any needed target area, providing medicinal solution(s) externally to an ailing body part for a variety of indications. Transdermal drug delivery when combined with heat increases the effectiveness of topical drug delivery. These indications include but are not limited to treatment of musculo-skeletal conditions, pain, arthritis, psoriasis, eczema, autism, stress, and a variety of skin disorders.

According to a paper published by Wade Hull, MS entitled Heat-Enhanced Transdermal Drug Delivery: A Survey Paper, “Much research is being done in order to find new and more effective ways to enhance the topical delivery of these drugs. Although complex chemical enhancers have been integrated into some transdermal delivery systems, physical agents such as electricity (iontophoresis), ultrasound (phono- or sonophoresis), and magnetism are becoming increasingly popular as enhancers.

An even simpler mechanism for externally regulating transcutaneous drug absorption is the application of heat. Heat is expected to enhance the transdermal delivery of various drugs by increasing skin permeability, body fluid circulation, blood vessel wall permeability, rate-limiting membrane permeability, and drug solubility. Diffusion through the skin, as elsewhere, is a temperature-dependent process, so raising the skin temperature should add thermodynamic drive. Heat is known to increase the kinetic energy of both the drug molecules and the proteins, lipids, and carbohydrates in the cell membrane. Heating prior to or during topical application of a drug will dilate penetration pathways in the skin, increase kinetic energy and the movement of particles in the treated area, and facilitate drug absorption. Heating the skin after the topical application of a drug will increase drug absorption into the vascular network, enhancing the systemic delivery but decreasing the local delivery as the drug molecules are carried away from the local delivery site.

Knutson et al. recently investigated the mechanisms involved in temperature-enhanced skin permeability. Results indicated that the increased skin permeability of lipophilic drugs results from temperature-induced alteration of the lipid structure, which involves the disordered arrangement of the lipid bilayer structure and its fluidization. Further studies indicate that temperature changes of approximately 5° C. are necessary to cause measurable changes in cell membrane permeability.

The effect of temperature on in vitro transdermal fentanyl flux was estimated by Gupta et al. using cadaver skin 5-degree range, and the drug flux approximately doubled. Given doubling of release rate in vitro with a 5° C. change in temperature, an in vivo study was conducted in 20 volunteers to determine regional skin-temperature differences under occlusion. Transdermal placebo systems (10 cm2) were placed on areas of the thigh, forearm, back, chest, and post auricular areas. The results indicated that skin temperature under occlusion does not differ sufficiently from site to site to cause different drug-input rates. Gupta et al. predicted that since “the diffusion process depends on the activation energy,” an increase in body temperature would increase the fentanyl permeation rate. Assuming that the diffusion rate from the delivery system remained unchanged during a 3° C. temperature increase, they predicted that the maximum serum concentration level at the middle of the 3-day application period would increase by 25% (from 2.1 to 2.6 ng/mL for a 100-mg patch).

Table 1 below shows examples of the use of heat with transdermal drug delivery.

TABLE 1 Percent Drug Temperature Solubility Increase (° C.) (g/100 mL) Barbital 20 0.629 138% 37 0.949 Phenobarbital 20 0.088 209% 37 0.184 Sulfadiazine 20 0.00616 161% 38 0.0099 Tolbutamide 27 0.0077 184% 37.5 0.0142

The instant invention supports the theory that moist heat is a more effective method for transdermal drug delivery than that of employing dry heat. An Internet publication, “Iontophoresis: Maximizing Treatment Effectiveness, James R. Scifers, DScPT, PT, SCS, LAT, ATC,” describing to improve the effects of active drug delivery using iontophoresis states, “Finally, for chronic conditions, apply moist heat prior to treatment in order to increase tissue permeability. Just like a hot shower opens the skin's pores, using a moist hot pack before treatment will make the skin more permeable to medication.” Iontophoresis under certain conditions can provide optimal results when iontophoretic electrodes are spaced greater than 1 cm apart and produce an electroporative depth penetration transport of drugs transdermally of up to 1 cm. With the use of moist heat employed with iontophoresis, it is hypothesized that the results will be further maximized until present, a physiotherapy therapy moist hot pack treatment was delivered, provided with the commercially available Hydrocollator Units sold by Chattanooga Corporation, Chattanooga, Tenn., USA. After 60 years, Chattanooga Group still makes its original Hydrocollator stainless steel tank tub for soaking their heated “Hot Pac”—a canvas bag filled with bentonite clay.

In current day, the hydrocollator unit has not changed since its initial conception that was invented by an Athletic Trainer, Lee Jensen, in 1947. A hot water heating unit is manufactured with a steel housing container tank for holding and heating of Hot Pacs. The Hot Pac unit tank is filled with water for submersing the packs underwater. An electrically heated heating element placed at the bottom of the unit tank causes the water to be heated. The hydrocollator “Hot Pac” moist heat packs are covered by a canvas material matrix containing within it “inert bentonite sand-like clay materials” that are placed, soaked, hydrated, and heated within a heated water reservoir tank. A vertical holding tray is provided for holding the packs for submerged heating. Hot Pacs are made and sold in a variety of large and small sizes for different body parts. When properly heated in the tank, the packs are then taken out of the reservoir to be placed, wrapped in towels of varying thickness before being dispensed on a target body part. Wrapping the Hydrocollator packs in towels prevents burning the patient. Hydrocollator packs are used only for the sole purpose of providing heat therapy for musculoskeletal indications. Hydrocollator current therapeutic options are the use of moist heat generated from the pack for treatment of pain, arthritis, muscle spasm, and a number of indications. However, there exist no good solutions for the delivery of both pharmaceuticals, etc. applied with moist heat, especially for use in a clinic or home environment. Hydrocollator heating units have many drawbacks, which are discussed herein. The steel tank units are clumsy and not user friendly. The tank temperature is not visibly read by the device making it difficult by the operator to easily regulate and control. Water temperature within the Hydrocollator tank unit is approximately 160° F.+(71° C.+), and the water scalding temperature is approximately 120° F. (49° C.). Tank hydrocollator water heating units do not notify the operator of the conditions within the tank in real time. The operator must manually put a thermometer in the hot water to manually record/log the unit water temperature. Hot water temperature measurement must constantly be observed by the operator to observe the heating units' daily thermal performance, which is time consuming. Also, there is no alarm system to alert the operator of a malfunction and may cause further liability to both practitioner and the patient. Further, the water levels in the tank must be constantly replenished due to heat-induced evaporation. Another drawback is when practitioners often have to inconveniently reach or bend over the hydrocollator tank. They have to clumsily use a tong to pick-up the packs, which are heavy with water and hydrated clay sand weight. Operators at times may try manually to handle the hot-packs with their hands when the tongs are unavailable or not accessible. The procedure of taking out the Hot-Packs from the water heating unit comes with the risk of burning themselves and also creating a hot wet mess. Further, the tank unit can often become unsanitary and requires constant cleaning and maintenance, causing potential unsanitary dangers to both practitioner and patient. When Hot Pacs are constantly used in a heated fluid bath environment, the Hot Pac canvas matrix becomes worn out. Subsequently, the Pac's matrix opens up and leaks out the Pac's internal contents, where it “leaches out” into the heating unit water tank causing a pungent, salient, unbecoming odor. Hot Pacs submersed under water under these conditions in a tank opens the possibility of contamination. Therefore, this type of Hot Pac immersion system housed in a tank is not conducive for a clean, neat, therapeutic clinical environment for both the practitioner and patient being treated. Hydrocollator heating units constantly need to be periodically drained, disinfected, and cleaned, causing practitioner's loss of valuable time. The hydrocollator tank model has the following warnings from the manufacturer:

Never adjust the thermostat too high. The thermostat is extremely sensitive to the slightest adjustment.

Clean the tank periodically as described in the maintenance portion of this manual.

Always replace Hydrocollator HotPacs as soon as they show signs of wear.

If the unit is to be left unattended for a period of time, unplug the unit, remove the packs, empty the water, and clean the tank.

Do not move the Hydrocollator while filled with water. Tipping over could result in burns to the user or others.

Always unplug the Hydrocollator from the power source before attempting to empty water from unit.

Always destroy and replace HotPacs which are exposed to contamination: hazardous or cleaning materials, bodily fluids, mold, etc.

Chattanooga Corporation, Instructions for the Use and Operation of the Hydrocollator M-2 Master Heating Unit, December. 1990.

The Hydrocollator system does not provide for optimum therapeutic heating effects and benefits for the patient and does not provide for a consistent and constant source for reheating while on the patient because it cools off over time. To dispense a hot pack practitioners take the hot-packs out of the stationery tank heating unit at one location of a room and must walk with the pack toward the patient at another location in the treatment room for placement directly on the patient. The Hydrocollator tank unit and packs do not provide any alerting mechanism to inform or alert both the practitioner or the patient regarding the temperature within the pack in real time, and prevent potential injury to the patient. Further, current day hot pack devices do not conveniently allow for moist heat combined with drug delivery packs applied directly to the skin. There are problems with the current options' lack of controlled treatment temperature and the inability to provide controlled moist heat for medicinal hot packs. Also, hydrocollator tank units are bulky, messy, and expensive.

In the conventional process of preparing hot packs, stupes, or fomentations, patients and health care practitioners had to immerse a medicinal pack by dipping and/or soaking the pack in a basin or sink of hot water until the pack was fully saturated with hot water. In the conventional practice preparing and dispensing medicinal packs, stupes, or fomentations, practitioners and users risked losing and over-diluting most or all of the medicines within the pack, wasting its contents in the sink basin. This wasteful, messy, makeshift practice and procedure caused potential loss and effectiveness of medicinal packs or stupes and their purpose and intended application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a passive in-office system and method for moist heat drug delivery in accordance with certain example embodiments.

FIG. 2 illustrates a passive home/mobile system and method for moist heat drug delivery in accordance with certain example embodiments.

FIG. 3 illustrates an active in-office system and method for moist heat drug delivery in accordance with certain example embodiments.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Embodiments of the invention can provide greater convenience and choice as an alternative to having oneself bath or immerse a body part or full body for hydrotherapy in a medicinal solution. This invention can be indicated and helpful especially for those individuals with a weak or debilitated constitution who cannot take a full-body medicinal or hot salt bath treatment. There is a need for portable, user-friendly, ergonomic, labor saving device to prepare and assist delivery of moist heat packs to the patient with a variety of therapeutic options in a controlled manner. In order to create a more effective, sanitary, time and labor saving, moist hot pack heating device to allow medicinal drug delivery and non-medicinal hot pack treatment, exemplary embodiments described herein can provide the various items at controlled temperatures of 32° C. and 37° C.

Exemplary embodiments involve a novel moist steam heating cabinet unit as a medical device for humidification, hydration, and dispensing of medicinal hot packs. The technology as described herein is an advancement over the conventional state of the art, and provides multifunctional options for both medicinal and non medicinal hot pack treatment, as well as for other applications and uses, for example, including creation, manufacturing, and curing of pharmaceutical compounds that require a controlled steam process and method. A moist heating device is a unit designed and constructed to deliver a timed, heated, fluidic steam coming from a moisture generating heating source. This moist heating unit and method employing steam heat activates the therapeutic potential of a portable topical compress or hot pack with a flexible applicator, of various shapes and sizes, for transdermal use and neat applications of a wet medicinal dressing. The moisture provides the activating liquid and fluidic environment for the flowing through, titrating, and permeating delivery of drugs or medicaments held within a medicinal pack. A portable accessory moist heat steam pad unit is provided for continuous dispensing of moist heat to a medicinal or non-medicinal hot pack applied to a patients target area.

This invention involves the combination of therapeutics and moist heat—deliver in a controlled manner (delivery of a therapeutically relevant amount of therapeutics to the skin at a therapeutically relevant rate).

The rate can be controlled by the controlled delivery of moist steam heat to the therapeutic-containing component. The combined moist heat/therapeutic will then be delivered to the skin in a controlled manner.

This instant invention provides the proper heat temperature in relationship to how much drug delivery is being delivered topically from medicinal pack. As the epidermis is exposed to moist heat temperature, the amount of drug transport through the skin incrementally increases. Increased heat causes increase drug delivery through the skin. Each drug has a different unique transdermal transport behavior across the skin in accordance to their molecular structure. The invention correlates the relationship between temperature degree of moist heat and affect of heat on the drug transport temperature mechanisms for both the drug and the skin. An LCD monitor will provide to the operator or patient a menu of options advising what temperature should be used with the medicinal or non-medicinal pack, timer for treatment, time clock, voice actuation, voice teacher regarding the device, alerts, etc.

The combined moist heat/therapeutic will then be delivered to the skin in a controlled manner.

The delivery of the drug can also be facilitated through the use of electrophoresis or iontophoresis on the skin. A permeable membrane of both negative and positive polarities placed on the human epidermis can be additionally put under the drug delivery medicinal hot pack.

Hydration of the drug permeating from the pack contents causes increase conductivity of the substance being delivered and lowers electrical impedance of the current at the dermal level, which increases permeability at the stratum corneum. The combination of moist heat and iontophoresis is novel.

The rate of release from the pack/stupe can be controlled by modifying the properties of the matrix. The matrix can be engineered to release aqueous and drug compounds. Another embodiment regards a portable heating pad device comprising a pack/stupe containing component and a heating component. The pack/stupe is moistened, and heat is applied through the heating component. The device can have a separate pack/stupe containing portion and a separate heat delivery system proximate to the pack/stupe containing portion. The pack/stupe is moistened, and the pack/stupe containing portion releases the moist therapeutic upon the application of heat from the heat delivery component. The pack/stupe containing portion can be engineered to provide for release of the moist heat and therapeutic when the moist heat and therapeutic are within a particular temperature range. The pack/stupe containing portion can also be engineered to release the moist heat and therapeutic at a particular release rate or range of release rates sufficient to achieve the desired therapeutic effect.

The delivery of the drug can also be facilitated through the use of electrophoresis or iontophoresis on the skin. A permeable membrane of both negative and positive polarities placed on the human epidermis can be additionally put under the drug delivery medicinal hot pack. Hydration of the drug permeating from the pack contents causes increased conductivity of the substance being delivered and lowers electrical impedance of the current at the dermal level, which increases permeability at the stratum corneum. The combination of moist heat and iontophoresis is novel.

The rate of release from the pack/stupe can be controlled by modifying the properties of the matrix. The matrix can be engineered to release steam heat in the range of 20-43 degrees centigrade. In certain example embodiments, an electrically powered moist steam heat cabinet medical device provides a holding area and humid environment for controlled, neat, sterile, moist steam heat hydration of a therapeutic non-medicinal and medicinal pack. The device comprises a component into which the pack/stupe/etc. is placed to prepare it for use. The device delivers moist heat to the pack/stupe/etc. until a sufficient amount of moist heat is contained in the pack/stupe. Once the desired moist heat level is reached in the cabinet unit and pack/stupe, the pack/stupe can be applied to the skin to deliver the therapeutic in a controlled manner.

Additionally, in certain example embodiments, a removable and portable accessory component is placed, attached on top of the cabinet wall or ceiling and provides for continuing moist heat warming of a medicinal or non-medicinal drug treatment to a mammalian body part. The accessory device can receive a distilled hot water supply from the cabinet unit.

In certain example embodiments, this device is designed to provide the correct temperature and humidity for clean and easy dispensing of therapeutic hot pack(s). In certain example embodiments, the device is constructed for the purpose of increased effective application, utility of a medical device heating unit for the safe and effective transport and delivery of moist heat packs. In certain example embodiments, a moist heat apparatus cabinet is designed with four walls, a floor, and a ceiling creating a chamber; the chamber creates an open-air spaced oven-like environment. In certain example embodiments, the moist heat delivery apparatus can provide multiple options in a receptacle, container, or cabinet. The cabinet can be made of a heat, stain, and shatter-resistant material, such as plastic, fiberglass, Kevlar, stainless steel, or equivalent material. The inner walls of the cabinet have multiple steam spray heads placed directionally around all sides and on the top and bottom of the cabinet to deliver steam heat into the chamber. In certain example embodiments, an improved hot pack unit dispenser is provided with modular construction with guide rails on the internal side walls of the cabinet for conveniently holding trays, racks, shelves, and dishes for holding hot packs, stupes, and fomentations within a cabinet heating chamber. The construction and design can allow for easy dispensing of hot packs on sliding trays or shelves to supply portable moist heat treatment to a patient. In certain example embodiments, the cabinet chamber is therefore created for placing of therapeutic hot packs or other medicinal compounds uniquely surrounded, immersed in an aqueous steam heat environment. Horizontal rows of shelves or trays can be provided with holes or other means of water permeability for allowing optimum humidification and moist heat conditions and utility for placement of a hot pack or other medicinal compounds in the steam heated chamber.

The internal floor and/or walls of the moist heat apparatus are embedded with jet spray heads or nozzles that focus a steam jet spray toward the therapeutic packs surface, enabling aqueous delivery surrounding the packs placed on the shelves within the cabinet chamber.

In certain example embodiments, a placement of rows of jet spray heads on the side walls and ceiling are aimed within the cabinet chamber for the delivery of aqueous steam directionally; a heated jet spray of steam/mist is aimed at various levels and angles for a controlled hydro-saturation of the packs placed on one or more shelves within the cabinet chamber. In certain example embodiments, when the steam jets are activated, the medicinal pack(s) and their drug contents becomes hydrated, primed for drug delivery applications.

In certain example embodiments, one or more rows of mobile vertical sliding shelves or trays, or dishes are held in place by guide rails allowing for easy access, ejection of, reaching, and handling of the portable therapeutic packs or optionally pharmaceutical compounds in a container resting on the trays, shelves, or dish; the tray or dish or shelves can be manually or mechanically ejected from the cabinet unit for easy dispensing of items placed on the tray, dish, or shelf.

In certain example embodiments, the practitioner can be prevented from contaminating the unit and self while preventing inappropriate handling and potential burning of the operator. In certain example embodiments, the steam heat cabinet apparatus device is manufactured with prefabricated parts having easy to assemble modular components. In certain example embodiments, to continue the therapeutic treatment from a medicinal or non-medicinal hot pack, a portable steam heating accessory attached to top of the unit can be easily removed, dislodged for portably providing continuous moist steam heat to be placed to rest directly on top of a medicinal or non-medicinal hot pack.

In certain example embodiments, in addition to manufacture of the medical device for industrial and clinical use, a small home model for one or two pack dispenser can be manufactured for home use.

In certain example embodiments, to provide a hot pack unit with a modular prefabricated construction, the water is contained within a tray shelf or cradle pan that becomes heated to dispense steam heat. The removable basket pan has handles on the sides, where the steam unit can be removed without having the operator/practitioner placing his or her hands directly while removing the pack being housed on the apertured bottom wall of the basket or cradle. In certain example embodiments, the moist heat unit can be readily formed and constructed of relatively few parts, which may be easily manufactured at relatively low cost.

In certain example embodiments, a multifunctional moist hot pack dispenser is provided for dispensing regular “off-the-shelf” commercially available hot-packs as well as medicinal packs. In certain example embodiments, a portable moist steam heat dispenser includes a housing having a hollow, generally vertical rear wall, a generally horizontal stand portion, and an overhanging top wall that extends generally horizontally from an upper portion of the vertical rear wall. A water dispensing reservoir is positioned on the vertical wall a substantial distance above the lower stand portion of the housing, and a collecting pan for hot water is positioned on the stand at one side of the cabinet apparatus. A hot water outlet is provided in the overhanging top wall directly above the basket and at one side of the hot pack dispenser. A superior removable hot water basket pan is provided with an outwardly extending square lip at its upper portion so that it may be supported thereby. This example embodiment that provides hot steam with a heat monitor is designed to be the portable steam heating unit that can be placed on top of a hot pack.

An interior collecting pan on the bottom of the cabinet floor recycles and re-circulates water back into the vertical rear wall. Should the water reservoir in the rear wall become insufficient or empty to operate the device, a monitor warning signal will go off to notify the operator that the water levels are too low. This prevents or guards against rapid loss of water and moisture in the unit.

In certain example embodiments, the water is distilled and sterilized within the unit to prevent outside unwanted contamination. In certain example embodiments, the portable component supplies moist heat on top of a medicinal pack, allowing hot water and medication(s) contents to move using gravity in the downward direction toward the skin, and to allow moist heat and heated water to course through a medicinal pack, enabling leaching out of the combined pack contents traveling toward the direction, destination and contact with the mammalian skin for medicinal and/or physiotherapy applications.

The device can provide sufficient moisture and dew level and, should this level be insufficient, an LCD monitor/alarm system will notify and warn the operator. A glass front door can allow the practitioner to view outside the conditions inside the cabinet.

Pharmaceutical compounds and chemical enhancers have a specific moist heat dew point humidity and temperature where it reaches an optimum point for hydration/water solubility where they can be able to become transdermally transported. This specific dew point and humidity can also have industrial applications in the creation of certain drug compounds that require a moist heat steam environment for their curing and manufacturing process as well as increasing their water solubility. Since each drug or pharmaceutical compound has specific heating, dew, and humidity point, the temperature in the cabinet must be controlled as to not cause any degrading, destruction, or change of chemical compounds produced for their specific intended therapeutic purpose.

Therefore, in certain example embodiments, a safe method is provided for a safe steam moist heating cabinet for controlling the amount of moist steam heat. Water dripping in a water feeder is turned into steam and disturbed via jets or nozzles. Thus, generated steam in the cabinet chamber is discharged through the steam channels, which keeps the inside of the cabinet connected to the outside of the cabinet. The temperature of steam passing through the steam channel is measured by a steam temperature measuring device. The amount of water fed from the water feeder is controlled in response to the measured temperature.

The steam cabinet device can have fans located on the side walls strategically placed so that temperature can be controlled for even cooling in the chamber. Further, fans assist in directionally focusing the steam mist toward the target pack or medicinal product lying on the shelf and create a unified consistent temperature in the chamber.

In certain example embodiments, the accessory attachment to the cabinet to provide continuous steam heating of packs with its electrical outlet or port can optionally be battery operated. In certain example embodiments, a flexible heating pad-like design is provided; the design having latches on the outer borders for holding and heating of the medicinal and non medicinal hot packs.

In certain example embodiments, within the heading pad, a system or mesh of flexible and malleable heating wires that are heated by electric means are encased in a water-proof, flexible material matrix in the first superior layer of the portable steam heating pad accessory unit. The heating component wiring has a separation plate that prevents seepage and interaction with the bladder and treatment area to avoid and prevent electroshock and burning.

The material matrix forms a safe barrier, preventing electroshock between the electrical heating aspect and the fluid dispensing aspect of the pack. The accessory moist heat or steam heating pad is made of a hypoallergenic and heat resistant material made of, for example, fiberglass, pyrofoil (ADL ISU LAFLEX, Inc., Ontario, Canada), that holds, surrounds the heating pad forming a “matrix” that creates a pad, allowing the packaging, holding, and dispensing of the moist steam heat or steam heat vapors.

The pack has a contact barrier material matrix that comes in contact with a medicinal pack and is comprised of a hypoallergenic polymer permeable and/or semi-permeable membrane heat resistant and hypoallergenic materials, allowing passive release of its contents in a slow, timed constant rate of permeation titrating through the barrier matrix to provide a desired rate of transdermal delivery of the medicaments in the medicinal pack below. Release of the bladder-medium. In certain example embodiments, the accessory applicator heating pad unit can be made various shapes and sizes that can be directly placed on top of a medicinal or non-medicinal hot pack that can be placed around any desired anatomical body part.

In certain example embodiments, the second layer below the top layer of the electrical heating component of the pad is separated by a waterproof, non-electrical conducting material matrix, comprising a bladder holding a water supply for the creation of aqueous steam heating. The bladder water supply is connected to a water outlet, which can be attached, hooked-up by an attachable hose via a cap opening in the bladder for filling. The device is designed to conveniently irrigate and slowly control filling the bladder reservoir with the proper amount of water from a water tap with distilled hot water supplied by the console unit. The bladder contains a network of multiple, porous supply tubing that delivers the fluid medium and that are responsible for regulating slow dispersion, irrigation, and titration of the fluid contents contained within the bladder reservoir via a system of branching ducts, allowing its contents to seep through the inferior aspect. The bladder layer is located superiorly on top of (being placed above) the packs' medicinal contents. The bladder layer is designed to release the fluidic contents within the reservoir to come in direct contact with the pack to allow moist heat to slowly seep through, permeate, and hydrate a medicinal or non-medicinal hot pack.

In certain example embodiments, a porous layer of the heating pad accessory is inferior to the bladder for slow leakage and seepage of moist steam heat. In certain example embodiments, this accessory heating pad device increases the device's utility and purpose, created to enhance the ability of portability of providing enhanced moist steam heating methods externally when medicinal or non-medicinal packs are not stored in the stationary console model. Through warming of the bladder by the electric component above, its application on the dermis allows increased stratum corneum and epidermal permeability, facilitating increased penetration of the medicaments being delivered topically. Warming or heating of the water contents enhances gradual release of the medicinal contents through the pack matrix. Therefore the present accessory hot-pack heating pad accessory dispensing system will provide a predetermined controlled rate for dosage, timed titration and permeation of its contents as desired or prescribed by the patients' physician or pharmacist for greater efficiency and accuracy.

In certain example embodiments, the moist heat pad provides a timer and temperature gauge with an alert system to assist the patient and the operator in providing the correct temperature and timing for delivering the appropriate therapeutic treatment. In certain example embodiments, the moist heat steam heating pad accessory has sensors that can be connected to a medicinal or non-medicinal hot pack or surface of the patient's skin to create a temperature loop system for maintaining a desired temperature for therapy and drug delivery. Hot packs can be dispensed with controlled temperature and do not require being applied in a thick toweling coverage to prevent burning the patient or cause hyperthermia.

In certain example embodiments, the heating pad accessory provides a semi-permeable membrane that is the contact layer of the moist heating pad with a pack or skin. This membrane can deliver the moist heat from the bladder reservoir. The membrane is non-irritating to the skin while administering a moist, heated fluid or alternatively passive or active delivery of a broad range of drugs.

In certain example embodiments, a combined moist heating pad system for delivery of moist heat and a pharmaceutical medium comprises a layer of permeable foam for retaining therein a quantity of pharmaceutical medium exhibiting at least partial ionization, and an electroconductive membrane disposed under the foam layer through which an aqueous solution or pharmaceutical medium passes, by passive or active transport through the membrane to provide moist heat and drug treatment therapy via the skin. The electroconductive membranes can employ the application of iontophoresis to increase transdermal drug delivery further. In iontophoresis, an electric field is applied to the electroconductive membrane toward the skin, which moves charged molecules in the electric field. If applied in the correct orientation, iontophoresis is effective to drive charged drugs into the skin, although iontophoresis can also drive uncharged drugs into the skin. Skin treatment with heat and water acts synergistically with iontophoresis. This action is because heat and water make skin more permeable, but do not actively drive molecules into the skin; the driving force remains diffusion. Iontophoresis provides an additional driving force via electrophoresis (or electroosmosis) to actively push drug molecules into the skin. Thus, the combination of moist heat, hydration, and iontophoresis will increase transdermal drug delivery compared to any subset of these three approaches.

In certain example embodiments, the transdermal drug delivery system is provided as an unlinked patch device with an electroosmotic, electroporous membrane comprising an inert biochemical substance that becomes actively electroosmotic when an electric charge is passed through the membrane. During iontophoresis, an electric current is passed into the membrane, and it becomes electro-bioactive, enabling the drug solution to be passed through the electrode membrane wall to a target area on the skin surface creating an electroporative effect.

In certain example embodiments, the dermal contact surface of the membrane is constructed out of substances close to the structure of human skin, for example, based on the membranes used in artificial kidney membranes such as sulfonated polysulfone (PSF), so as to be non-irritating. This construction can reduce skin rejection of polymers currently used to accomplish transdermal transport of drug solutions. Polysulfone membranes have been used for transdermal drug delivery; however, certain example embodiments employ a biomimetic and electroconductive membrane (ECM) that can be used in a moist heat environment with the aim of producing an electroconductive membrane (ECM) with low electrical resistance and appropriate mechanical properties, that will not break down during use, and with heat temperatures provided by moist heat that would be safe and effective.

The bladder reservoir can be additionally provided with a foam layer placed on top of the membrane for controlled microtitration of aqueous or drug solutions.

In another embodiment, the patch is provided with a biosensor for sensing when the drug or water is no longer present in the bladder reservoir, alerting the patient or physician via an audible or visual signal.

In certain example embodiments, the temperature of a stupe, fomentation, or pack from the console unit is maintained for continuance of optimum therapy conditions for either drug delivery or physiotherapy.

An embodiment of how this can be accomplished in a portable component of the console model for commercial and home use is the placement of a heated bladder reservoir allowing for permeating, slow-timed steam/moist heat above a pack, fomentation, or stupe for delivering consistent therapeutic temperature. The top aspect of the console can become detached, as is known as the top bladder layer, providing for a portable accessory moist drug delivery heating pad.

A stupe can also be made into a tea bag like two-sided pack to provide an easy flow through drug delivery system that can be placed in a series of permeable pockets within the moist heat accessory device.

The technology disclosed in this patent application provides a solution to the controlled delivery of therapeutics and moist heat. Prior approaches to drug delivery did not allow severally or jointly the combination of controlled moist heat treatment with or without transdermal iontophoresis.

One embodiment comprises a moist heat delivery component that is placed proximate to a pack/stupe/etc., wherein the moist heat delivery component releases moist heat in manner sufficient to result in the precise titration of therapeutic agent from the pack/stupe/etc. to the skin and precise rate of moisture permeating through the pack which determines the rate of drug permeating to the skin.

The moist heat delivery component releases moist heat at a rate sufficient to result in the controlled release of therapeutically relevant amount of drug from the pack/stupe/etc.

The example embodiments described in this patent herein are an innovation in the field of drug delivery, solving problems of application, utility, and portability. It is designed as an effective, time-saving applicator system to alleviate the excessive fuss, guess work, and clumsy application of creating “home-made” packs. Medicinal mineral or Epsom salt pack applications in a pack, stupe, or fomentation in accordance with the example embodiments described herein can be easily applied to any needed target area, effectively providing controlled topical delivery of medicinal solutions externally to an ailing body part or area. The example embodiments, described herein can control, regulate the dosage and rate of what is being dissolved, evacuated, transported, absorbed, or released from the medicinal pack through its barrier matrix. The rate of release can be controlled by gravity, vacuum, or other force acting on the device. The percolating effect of the moist heat provides a pump like force exerted from a controlled build up of steam motive forces by means of pressure pushes the drug through the stupe, pack, or tea bag like patch that increases the flow of drugs through them toward the skin.

In certain example embodiments, a device that provides moist heat to medicinal hot packs provides drug and medicament delivery, and can also be used for providing moist heat to non-medicinal drug delivery packs.

The invention is a device to deliver moist heat and therapeutics. The moist heat and therapeutics can be A is mixing with B at controlled rate in a hydrous compound to go to C.

The device cab provide for the controlled delivery of moist heat and therapeutic compounds to the skin.

A safety temperature sensing component can sense temperature of at least one location of skin, therapeutic pack, and moist heat delivery component, alert the user/practitioner when desired temperature range is reached, and alert the user/practitioner of unsafe temperature

When the pack is activated via hydration, its contents cross through the material matrix creating a passive transdermal drug delivery stupe to the surrounding dermis being in direct contact with the pack applicator.

The medicinal pack or stupe applicator is topically and easily applied for slow, timed, and controlled release of its contents for allowing a gradual slow “oozing out” of its medicinal contents via the material matrix to relieve the affected area. When the pack applicator cools off or its' contents are released and used up, another applicator pack, stupe, and fomentation product can be employed to repeat the treatment procedure as many times as desired or needed.

An additional example application regards final-step manufacturing and/or curing of pharmaceutical compounds with some degree of instability for intradermal administration. This process is concluded when the moist heat percolates through a reservoir (pack or stupe, analogous to hot water percolating through a coffee bag in a coffee brewing device). In certain example embodiments, the “percolate” comes into contact with and delivers the pharmaceutical agent to the skin. This permeable reservoir system can also be mounted between electrodes to further modulate dermal transport via iontophoresis, with the application of DC current.

In certain example embodiments, a cartridge packaging holds and contains the drug in the cartridge, wherein moist heat travels through and transports the drug in a portable medical device capable of combining iontophoresis with moist heat. This combination can increase transdermal drug delivery. Hot packs are prepared that administer a controlled dose of heat and water in the form of steam to the skin. This preparation allows administration of the right amount of heat and water to effectively increase transdermal delivery without causing unacceptable side effects, damage, or pain to the skin. Heat can increase the rate of transdermal drug delivery in a number of ways. First, diffusivity of drugs is increased with increasing temperature, which means drugs will diffuse more rapidly into the skin at higher temperature. Typically, drug solubility increases at elevated temperature, which also increases the amount of drug delivery into the skin. In addition, the main barrier to drug delivery into the skin is the lipids of the stratum corneum. Some of these lipids undergo a phase transition near body temperature and the lipids in general become more fluidized at higher temperature. This additionally makes the skin more permeable to increase transdermal delivery. Blood flow also increases at elevated temperature, which clears drugs from the skin and thereby increases the concentration gradient-driven diffusion of drugs into the skin. Altogether, these multiple effects make application of heat to the skin to elevate its temperature an effective way to increase transdermal drug delivery. In the example embodiments described herein, water can increase the rate of transdermal drug delivery by increasing skin hydration. Increased skin water content can fluidize the stratum corneum lipids, thereby increasing skin permeability. Water can also pool to form highly permeable domains in the skin that provide pathways for increased transdermal drug transport. Water also swells the corneocytes of the stratum corneum, which distorts lipid structure to increase skin permeability. Finally, increased skin water content can increase solubility of water-soluble drugs, which increases the amount of drug delivery into the skin. Altogether, these multiple effects make application of water to the skin to increase skin hydration an effective way to increase transdermal drug delivery. The example embodiments described herein combine these two effects of heat and skin hydration to be more effective to increase transdermal drug delivery than either one effect alone. Both heat and hydration can increase drug diffusion through the skin by disrupting lipid structure in the stratum corneum and can increase drug solubility in the skin, which, together, increase transdermal drug delivery. While extensive hydration of the skin is likely to be well tolerated by patients, excessive heating will cause discomfort and possibly damage the skin. Therefore, one example embodiment includes a control of the temperature of the heat applied to the skin and, in that way, achieves an optimal temperature that increases transdermal delivery without unacceptable side effects.

In certain example embodiments, heat and application are timed and monitored either by the operator manually or by a programmable computerized mechanism that insures the various modalities being delivered by the instant invention are accurate, and which have the ability to employ exact timing, moist heat temperature, moist steam heat pressure, and electrical currents at specific intervals for optimal therapy; therefore, the device is created to prevent overheating or hyperthermia, as well as to prevent an “ionic shift” due to the epidermis being exposed for more than a period of, for example, five minutes at various positive or negative electro-iontophoretic current strengths. The modalities of moist heat combined with the iontophoresis delivery mechanisms are programmed into the medical device at timed intervals employing on/off settings. The intervals can be done jointly together or severally independently of each other to create optimum safe and effective treatment or specific treatments a patient requires as needed to an anatomical targeted area of the human or mammalian body. The device is therefore able to provide safe and effective drug delivery while preventing burning or damaging of the skin either by electrical or by means of moist heat hyperthermia. In the instant invention, the use of moist heat technology in combination with iontophoresis uniquely activates the pack and its drug contents to become ionized for active drug delivery via electro-transport. The iontophoresis electrical current is also applied to both the skin surface and to the pack to accomplish the electro-transport of the contents of the medicinal pack and pharmaceuticals topically in contact with the skin/patient's target treatment area.

Example embodiments will now be described further with reference to FIGS. 1-3. FIG. 1 illustrates a passive in-office system and method for moist heat drug delivery in accordance with certain example embodiments. FIG. 2 illustrates a passive home/mobile system and method for moist heat drug delivery in accordance with certain example embodiments. FIG. 3 illustrates an active in-office system and method for moist heat drug delivery in accordance with certain example embodiments.

The stationary cabinet console model holding unit is designed to provide placement for sized packs, stupes, and fomentations of various sizes in preparation for transdermal drug delivery. The cabinet console generates moist heat for the purpose of hydrating moist heat to the drug containing packs, to release the medicament to be supplied to the skin. The packs when moisturized are attached to an accessory applicator where it receives a continuous supply of moist heat in combination with electro-iontophoresis for transdermal treatments. The accessory applicator provides an attachment of the packs where both moist heat and iontophoresis can be supplied from the applicator in contact with the medicinal pack when also applied to the human or mammalian body.

Another embodiment is having a console model where the cabinet device can hover over a pack, stupe, pad, or fomentation thereby applying moist heat and iontophoresis, keeping a fixed position of the medicinal packs to a patient lying supine, prone to any anatomical body part. The cabinet is embodied to be attached directly and is part of the applicator where it can supply the stupe, pack, or fomentation with moist heat and transdermal iontophoresis as applied to the human or mammalian anatomy. The console model can provide iontophoresis via an electric generator built into the console or alternately to be supplied by other FDA approved iontophoresis generators. The cabinet console is designed with female jacks to plug in currents used for iontophoresis where electric wiring is adjacently supplied distributed along with the steam tubing providing moist heat where it can be supplied to the medicinal heating pack with male jacks attachment to transdermal electrodes in contact with the human or mammalian body.

Another embodiment is where a moist heat apparatus applied is on top of the medicinal pack, and the iontophoresis electrodes are applied to the skin. The applicator accessory device can also be designed in various shapes and sizes, either as a rigid clam shell or flexible device (held by, for example, a Velcro strap) that encompasses the human or mammalian body. The flexible applicator is designed to insure that the stationary applicator and medicinal packs are being held in place.

The example portable accessory version comprises a moist heating pad that provides a moist steam heat and electric currents for iontophoresis supplied from a miniature cabinet or console model. The accessory model has a tubing using steam heat to the unit. The accessory in this embodiment is an applicator that contains one or more small unit packs, for example, like a series of tea or coffee bags, holding one or more anhydrous or hydrous medicament in these tea bags. The medicaments become activated with the use of moist heat for transdermal drug delivery. The device is therefore a multifunctional device for activation of all packs, stupes, fomentations, or tea bag (open-ended, two-sided patch or pack).

In one example embodiment, the applicator does not allow for run off by a seal containment in the applicator. When activated by moist heat, the tea bag pack, patch, stupe are placed in holding cells or by permeable pockets or pouches within the applicator in contact with the skin. Within, the applicator is supplied with transdermally placed electrodes on each side of a miniature pack, stupe, tea bag that have each tea bag endowed with single or a line of multiple positive and negative electrodes on each side for the purpose of providing electroporation in combination with moist heat in contact with the human skin. This applicator has conduits throughout for distribution of moist heat to supply placement of the “tea bag packs” within for release of its contents transdermally.

The applicator can also be designed to apply moist heat and electroporation directly to the skin when a topical cream is applied. The moist heat coming from the heating unit provides a pump like pressure and moist heating simultaneously to push the drug through the pack.

The miniaturized cabinet applicator appliance can be both portable in communication with and miniaturized into an applicator that can be placed around the circumference of a body part that requires constant heating and fluidic supply. The pack or tea bag pack, stupe is loaded into a receptacle area where it is activated by the moist heat moving through the pack. The moist heat moves through the applicator via capillary circulation from tubing that is attached to the console generator providing drug delivery transport toward the human skin. Alternatively, a network of spray jets in the accessory model provides the right amount of moist heat above and to the two sided electrode pack/tea bag that is in contact with the skin for transdermal drug delivery.

The primary utility is the use of iontophoresis with moist heat applicator enclosed in an “encased environment” applied to the skin, which defines the utility of the patent, however, the embodiments can be made to suit the stationary console model for treatment in the doctor's or therapist's office and medical device miniaturized for portability. In one embodiment, the applicator can also be connected to a steam heating unit for continuous supply of moist heat in a timed-controlled temperature manner. The steam heating also supplies pressure for pumping of fluids to the console/pressure resulting from the formation by steam pressure and can also increase transdermal drug delivery.

The example embodiments described herein can be used with computer hardware and software that perform the methods and processing functions described herein. The systems, methods, and procedures described herein can be embodied in a programmable computer, computer-executable software, or digital circuitry. The software can be stored on computer-readable media. For example, computer-readable media can include a floppy disk, RAM, ROM, hard disk, removable media, flash memory, memory stick, optical media, magneto-optical media, CD-ROM, etc. Digital circuitry can include integrated circuits, gate arrays, building block logic, field programmable gate arrays (FPGA), etc.

Embodiments may comprise a computer program that embodies the functions described and illustrated herein, wherein the computer program is implemented in a computer system that comprises instructions stored in a machine-readable medium and a processor that executes the instructions. However, it should be apparent that there could be many different ways of implementing embodiments in computer programming, and the embodiments should not be construed as limited to any one set of computer program instructions. Further, a skilled programmer would be able to write such a computer program to implement an embodiment of the disclosed embodiments based on the appended flow charts and associated description in the application text. Therefore, disclosure of a particular set of program code instructions is not considered necessary for an adequate understanding of how to make and use embodiments. Further, those skilled in the art will appreciate that one or more aspects of embodiments described herein may be performed by hardware, software, or a combination thereof, as may be embodied in one or more computing systems. Moreover, any reference to an act being performed by a computer should not be construed as being performed by a single computer as more than one computer may perform the act.

The example systems, methods, and acts described in the embodiments presented previously are illustrative, and, in alternative embodiments, certain acts can be performed in a different order, in parallel with one another, omitted entirely, and/or combined between different example embodiments, and/or certain additional acts can be performed, without departing from the scope and spirit of various embodiments. Accordingly, such alternative embodiments are included in the following claims, the scope of which is to be accorded the broadest interpretation so as to encompass such alternative embodiments.

Although specific embodiments have been described above in detail, the description is merely for purposes of illustration. It should be appreciated, therefore, that many aspects described above are not intended as required or essential elements unless explicitly stated otherwise. Modifications of, and equivalent components or acts corresponding to, the disclosed aspects of the example embodiments, in addition to those described above, can be made by a person of ordinary skill in the art, having the benefit of the present disclosure, without departing from the spirit and scope of embodiments defined in the following claims, the scope of which is to be accorded the broadest interpretation so as to encompass such modifications and equivalent structures. 

What is claimed is:
 1. A moist steam heat cabinet apparatus, comprising: a cabinet having a floor, sides, and an inner lining; and an electrically powered moist steam heat cabinet medical device that provides a holding area and humid environment for controlled neat sterile moist steam heat hydration of a therapeutic non-medicinal and medicinal pack, the moist heat cabinet having a multiple arrangement of steam spray nozzles around the sides and floor of the inner lining of the cabinet, the cabinet being of various shapes and sizes, the device delivering moist heat to prepare hot packs/stupes/fomentation until a sufficient amount of moist heat is contained in the pack/stupe at a correct temperature and is ready for topical dispensing to a mammalian or human body part.
 2. The moist steam heat cabinet apparatus as in claim 1, having a controlled temperature exhibited on a display temperature control heating display board, the controlled temperature being pre-determined according to a drug's susceptibility and ability to be optimally activated thermally and delivered transdermally, the controlled temperature exhibition alerting a practitioner of pack temperature within the cabinet.
 3. The moist steam heat cabinet apparatus as in claim 1, wherein a controlled spray mist of water fluid hydrates drug delivery packs with a multiple mini-series of aligned jets along the length of the pack, wherein spray jets on the side walls are designed to deliver exact amounts of heat moisture with a spray mist ejection to allow total areas of the pack to become hydrated and heated to a desired temperature without loss or over-leaching out of the drug contents.
 4. The moist steam heat cabinet apparatus as in claim 1, further comprising a sliding shelf or tray disposed in the cabinet and with levels and horizontal rows of open spaced water permeable holding shelves for the holding and storage of the pack in the cabinet, wherein the sliding shelf or tray comprises an ejectable sliding shelf or tray that can be optionally removed manually with pre-manufactured handles for easy removal of the shelf or tray while holding/dispensing of its contents.
 5. The moist steam heat cabinet apparatus as in claim 1, further comprising an electronic indicator that indicates that the drug delivery pack within the cabinet and placed on the shelf or tray are ready for use.
 6. The moist steam heat cabinet apparatus as in claim 1, wherein the spray jets provide an appropriate timed moisture for each pack placed in the cabinet placed in rows horizontally, obliquely, or vertically.
 7. The moist steam heat cabinet apparatus as in claim 1, wherein subdivided placement of the packs arranged individually in rows allows moisture to slowly titrate to the packs without loss of their contents.
 8. The moist steam heat cabinet apparatus as in claim 1, wherein the apparatus is self-cleaning.
 9. The moist steam heat cabinet apparatus as in claim 1, wherein the apparatus is portable for home use or is a stationary console for office use that can provide transdermal iontophoretic drug delivery.
 10. The moist steam heat cabinet apparatus as in claim 9, further comprising an applicator in a plurality of portable shapes and sizes that generate moist steam heat and that can be flexibly worn around a body part, torso, or upper or lower extremity independently from the moist heat cabinet, wherein the applicator comprises a moist heating applicator that can be severally or jointly connected to the console model supply of moist heat via connecting tubing providing a supply of moist heat, which can thereby provide continuous moist heat independently of the console unit.
 11. The moist steam heat cabinet apparatus as in claim 9, wherein the apparatus transports moist heat through heat resistant tubing sending and distributing moist steam to the applicator and to the pack(s), stupe(s), and fomentation(s) and to a mammalian or human body part.
 12. The moist steam heat cabinet apparatus as in claim 9, wherein the applicator is connected to, generates, or transmits an electric current from a rechargeable battery and/or direct wall outlet power source, wherein the power source provides an electric current for both iontophoresis and moist heating to the applicator over an anatomical target area being treated.
 13. The moist steam heat cabinet apparatus as in claim 1, wherein the activation of a drug delivery pack, stupe, or fomentation comprises connection in conjunction with an electrotherapy generator that provides direct and galvanic currents to produce at least one of iontophoresis, electroporation, and electrophoretic treatments.
 14. The moist steam heat cabinet apparatus as in claim 1, wherein the apparatus comprises a plurality of specific spray mist settings comprising a setting for regular hydrocollator packs and a setting for medicinal packs.
 15. The moist steam heat cabinet apparatus as in claim 1, wherein the apparatus comprises a specific temperature for a medicinal pack according to a drug employed in the medicinal pack or a non-medicinal pack according to a type of the non-medicinal pack.
 16. The moist steam heat cabinet apparatus as in claim 1, wherein transport and permeation of drugs are accomplished by at least one of gravity, vacuum pressure, steam pressure, and iontophoresis.
 17. The moist steam heat cabinet apparatus as in claim 1, further comprising a portable, removable moist heating pad that that creates steam and that is placed on top of a pack, the pad for alternate transfer from the apparatus and placement for direct contact on the human skin or over a medicinal or non-medicinal pack, to maintain continuous steam heat to a medicinal or non-medicinal pack, the pad comprising latches to hold a pack securely below the pad to allow clean and neat placement of the device with the pack to a patient.
 18. The moist steam heat cabinet apparatus as in claim 1, further comprising a clam-shell or strapping method to hold a pack, stupe, or fomentation in place.
 19. The moist steam heat cabinet apparatus as in claim 1, further comprising an electric moist heating pad accessory device that provides moist steam heating currents to electrodes that contact with an aqueous solution for at least one of physiotherapy and iontophoresis treatment.
 20. The moist steam heat cabinet apparatus as in claim 1, wherein the apparatus produces steam hydration with a temperature ranging from 20-200 degrees Fahrenheit, and wherein the portable moist heat system is applied to a skin surface of a human user, and wherein the human skin maintains a temperature of less than about 43 degrees Celsius during the transfer of moist heat. 